1. Promoting the rational use of medicines Hans V. Hogerzeil, MD, PhD, FRCP Edin WHO Essential Drugs and Medicines Policy October 2002

2. 2 RDU Overview of the presentation n Access framework n Examples of irrational use of medicines n Measuring drug use (indicators) n How to promote rational prescribing ä Proven effective interventions ä Probably effective interventions ä Probably ineffective interventions n Promoting rational prescribing in the private sector

3. 3 RDU Practical implications of the access framework 1. Rational selection 4. Reliable systems 2. Affordable prices 3. Sustainable financing ACCESS TO ESSENTIAL MEDICINES Access framework

4. 4 RDU Example irrational use Irrational use of medicines is a widespread hazard to health n Only half of 102 countries surveyed regulate drug promotion n In some areas, by age 2 children have had more than 20 injections n 15 billion injections aregiven per year - and half of them are unsterile

5. 5 RDU Published examples of irrational prescribing in teaching hospitals in developing countries n Yemen 1990: 68% of hypertensive patients receive diazepam; 80% of UTI receive furosemide, 80% of osteoarthritis receive vitamins n Ilorin 1991: 33% of inpatients are on tranquillizers n Kathmandu 1992: Only 70% of medicines prescribed are from the national list of essential medicines n Thailand 1991: 79% of surgical antibiotic prophylaxis is inappropriate (choice, dose and/or duration) n South Africa 1991: 54% of antibiotic treatment in gynaecology inpatients is inappropriate Example irrational use

6. 6 RDU Examples of irrational prescribing from 4800 general practices in the UK (1995) n Ulcer healing medication used presumptively n In 0-90% of patients,SSRIs have replaced tricyclic antidepressants n In 0-56% of patients, buspirone has replaced diazepam (300x as expensive) n 0-97% of patients on beta-blockers receive long-acting betablockers (16-25x as expensive) n Other inhalors prescribed instead of salbutamol: (cost 8x) n Combination medicines (cost up to 16x) Example irrational use

7. 7 RDU How to measure irrational drug use? WHO/INRUD indicators (1) Prescribing indicators n Average number of drugs per encounter (<2) n Percentage of drugs prescribed by generic name (close to 100%) n Percentage of encounters with an antibiotic prescribed (<30%) n Percentage of encounters with an injection prescribed (<10%) n Percentage of drugs prescribed from EDL or formulary (close to 100%) Measuring drug use

8. 8 RDU How to measure irrational drug use? WHO/INRUD indicators (2) Patient care indicators n Average consultation time n Average dispensing time n Percentage of drugs actually dispensed (100%) n Percentage of drugs adequately labelled (100%) n Patients knowledge of correct dosage (100%) Facility indicators n Availability of copy of EDL or formulary (100%) n Availability of key drugs (100%) Measuring drug use

9. 9 RDU Promoting rational prescribing: Proven effective interventions n Standard treatment guidelines, when evidence-based, developed with end-users, with active dissemination and follow-up n Essential Medicines lists, when linked to treatment guidelines and used for training and supply n Hospital Drugs and Therapeutic Committees n Undergraduate training n Comprehensive approach, with all components Interventions

10. 10 RDU The Essential Medicines Target SS All the drugs in the world Registered medicines National list of essential medicines Levels of use Supplementary specialist medicines CHW dispensary Health center Hospital Referral hospital Private sector Selection

11. 11 RDU Clinical guidelines and a list of essential medicines lead to better prevention and care Health Technology and Pharmaceuticals List of common diseases and complaints Training and Supervision Financing and Supply of drugs Treatment guidelines Treatment choice Prevention and care Essential medicines list / National formulary Selection

12. 12 RDU Example of challenge: New essential drugs are expensive Antibiotics for gonorrhoea: 50-90x price of penicillins Antimalarial drugs: chloroquine $0.10 per treatment artemether-lumefantrine $2.50/pp (25x) atovaquone-proguanil $40/pp (400x) Antituberculosis: $15 for DOTS vs $300 for MDR (20x) Antiretrovirals:$300-600/year; but 38 countries with a drug budget <$2 pp/year Challenges

13. 13 RDU WHO Model List of Essential Drugs n 1977 First Model list published, ± 200 active substances n List is revised every two years by WHO Expert Committee n Last revision (April 2002) contains 325 active substances n 2002 Revised procedures approved by WHO The first list was a major breakthrough in the history of medicine, pharmacy and public health Médecins sans Frontières, 2000 Selection

14. 14 RDU The WHO Model List of Essential Medicines is a model product, model process and public health tool Model product: list of essential drugs with information Core list: minimum drug needs for a basic health care system, listing the most cost-effective drugs for priority conditions (selected on the basis of public health relevance and potential for safe and cost-effective treatment). Complementary list: essential drugs for which specialised diagnostic or treatment facilities may be needed Selection

15. 15 RDU WHO Essential Medicines Library Combining information from various partners WHO Model List Summary of clinical guideline Reasons for inclusion Systematic reviews Key references WHO Model Formulary Cost: - per unit - per treatment - per month - per case prevented Quality information: - Basic quality tests - Intern. Pharmacopoea - Reference standards Clinical guideline BNF WHO clusters MSH UNICEF MSF WHO/EDM WHO/EC, Cochrane Statistics: - ATC - DDD WCCs Oslo/Uppsala Selection

16. 16 RDU The WHO Model List of Essential Medicines is a model product, model process and public health tool Model process: example for national committees n Independent Membership of the Committee, careful consideration of conflict of interest n Transparent process, standard application, web review n Link to evidence-based clinical guidelines n Systematic review of comparative efficacy, safety, cost- effectiveness and public health relevance n Rapid dissemination, electronic access n Regular review Selection

17. 17 RDU National Essential Drugs List < 5 years (127) > 5 years (29) No NEDL (19) Unknown (16) By Dec.1999: 156 countries with EDLS 1/3 within 2 years 3/4 within 5 years The essential drugs concept is nearly universal a floor, not a ceiling - applied differently in different settings Countries with an official selective list for training, supply, reimbursement or related health objectives. Some countries have selective state/provincial lists instead of or in addition to national lists. Achievements

18. 18 RDU 135 countries have treatment guidelines, formularies Achievements Treatment guidelines and formulary manuals put the essential drugs concept into clinical practice

19. 19 RDU Training in rational prescribing has expanded in universities throughout the world DAPs role n Problem-based pharmacotherapy n In 21 languages n For medical students, clinical officers n Measurable improvement in prescribing n Now also: Teachers Guide to Good Prescribing Achievements

20. 20 RDU Impact of problem-based pharmacotherapy teaching on examination scores (Argentina, 1999-2002) 25,2 40 41,5 52 42,7 36 37,6 36 24,4 16 15 9,5 5,9 2,4 6,9 8,4 0%20%40%60%80%100% 2002(n=131) 2001(n=855) 2000(n=559) 1999(n=802) 34-56-7 > 8 Interventions

21. 21 RDU Example of an indicator survey time series: Percent prescriptions by generics, from EDL, and actually dispensed (Delhi State, 1995-2000) Percent Year under review Measuring drug use

22. 22 RDU Trends in research: From drug utilisation to cost-effective intervention (1) Drug utilisation studies tend to be descriptive, aggregated data : WHAT? Indicator studies more focused on rational drug use: WHAT? HOW MUCH? Qualitative studies WHY?

23. 23 RDU Trends in research: From drug utilisation to cost-effective intervention (2) Intervention studies HOW MUCH? WHY? (intervention) HOW MUCH NOW? Conclusion DOES IT WORK? IS THE INTERVENTION EFFECTIVE? Management studies IS THE INTERVENTION REPRODUCABLE? IS IT COST-EFFECTIVE?

24. 24 RDU Trends in research Example: Is it reproducable and cost-effective? Mexico (1992-1994) ResearchDistrictState Adequate treatment Diarrhoea: % change46.725.629.3 ARI: % change32.628.8 8.5 Cost-benefit ratio Diarrhoea: 3.3 3.9 4.4 ARI:16.218.421.6 Source: Guiscafre et al. Arch Med Res 1995; 26, Supp. S31-39

25. 25 RDU Promoting rational prescribing: Interventions which need more testing Probably effective: n Drug sellers interventions n Public education n Changing fee structure Probably ineffective: n Drug information bulletins and other printed materials n Banning ineffective/dangerous medicines n Arbitrary prescription limitations, counter signatures n Traditional stand-up lecturing Interventions

26. 26 RDU Promoting rational prescribing: Possible interventions in the private sector n Regulation: market approval, re-licensing, re-evaluation per therapeutic category, regulation of promotion n Training: basic training, national clinical guidelines, continuing medical education by universities and professional bodies, re-licensing of professionals on basis of education points, district DThCommittees, medical audit, patient information leaflets, public education n Financial incentives: separate prescribing from dispensing, dispensing fee (flat or tiered), price controls on generic/brand drugs, contracting out n Insurance: reimbursement limited to essential medicines, reference pricing Interventions

27. 27 RDU Where to start in countries with a strong private sector? n Regulation: market approval, re-licensing, re-evaluation per therapeutic category, regulation of promotion n Training: basic training, national clinical guidelines, continuing medical education by universities and professional bodies, re-licensing of professionals on basis of education points, district DThCommittees, medical audit, patient information leaflets, public education n Financial incentives: separate prescribing from dispensing, dispensing fee (flat or tiered), price controls on generic/brand drugs, contracting out n Insurance: reimbursement limited to essential medicines, reference pricing Interventions

28. 28 RDU Conclusion n Good experiences, policy advice, training tools and national expertise are available n Future of essential medicines lies with the public sector and insurance systems n There are many effective interventions possible for the private sector

29. Thank you www.who.int / medicines